Actively Recruiting
Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
Led by University of California, San Diego · Updated on 2025-11-05
76
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation (SI), while exploring cortical inhibition measures in this treatment paradigm. In this proposed study, the investigators will evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC compared to accelerated intermittent theta burst stimulation (aiTBS) over the left DLPFC in participants with TRD and SI. Additionally, the investigators aim to identify neurophysiological targets through which bilateral aTBS induces remission of SI in TRD differentially from aiTBS.
CONDITIONS
Official Title
Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Diagnosis of major depressive episode confirmed by Mini-International Neuropsychiatric Interview (MINI) with HRSD score of 18 or higher
- Ongoing suicidal ideation confirmed by Beck SSI score of 4 or higher
- Passed TMS adult safety screening and MRI safety screening
- Failed to respond to adequate doses of two antidepressants or unable to tolerate at least two separate antidepressant trials
- Psychiatric illness due to a general medical condition ruled out
- Voluntary outpatient capable of consenting to treatment and seen at UC San Diego Health Interventional Psychiatry program
- Able to follow the treatment schedule
You will not qualify if you...
- Diagnosis of substance use disorder within the last 3 months
- Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- Diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within last year), anxiety disorders, or dysthymia causing greater impairment than major depressive disorder
- Diagnosis of any personality disorder causing greater impairment than major depressive disorder
- Suicidal ideation requiring involuntary hospitalization
- Currently pregnant or lactating, or women of childbearing age without adequate birth control
- Non-correctable significant sensory impairment
- Not capable of consenting to treatment or unsuitable for outpatient treatment
- Unstable major medical illness, cardiac pacemaker, implanted medication pump, significant neurological disorder or brain injury
- Presence of intracranial implants or metal objects near the head that cannot be safely removed
- Taking more than 2 mg daily of lorazepam (or equivalent) or any dose of anticonvulsant that may limit rTMS efficacy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCSD Interventional Psychiatry
San Diego, California, United States, 92127
Actively Recruiting
Research Team
I
Interventional Psychiatry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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